FDA Orange Book
Is there a generic for Pyrukynd?
Pyrukynd contains mitapivat. Orange Book status for every listed strength, the approved generic makers, and the listed patents and exclusivities.
Source: FDA Orange Book data file dated 2026-10-09. Publisher page
No. The Orange Book lists no active FDA-approved generic (ANDA) for Pyrukynd (mitapivat). The Orange Book shows its last listed patent expires July 31, 2041 and its last listed exclusivity ends February 17, 2029.
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Pyrukynd products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| tablet, oral | EQ 20MG BASE | Marketed (Rx) | None | 0 | None |
| tablet, oral | EQ 50MG BASE | Marketed (Rx) | None | 0 | None |
| tablet, oral | EQ 5MG BASE | Marketed (Rx) | None | 0 | None |
NDA 216196, held by AGIOS PHARMACEUTICALS INC. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Pyrukynd patents
| Patent | Expires | Covers | Use code | NDA |
|---|---|---|---|---|
| 9682080 | May 3, 2032 | Method of use | U-3319 | 216196 |
| 9980961 | May 3, 2032 | Method of use | U-3319 | 216196 |
| 10632114 | May 3, 2032 | Method of use | U-3320 | 216196 |
| 9193701 | October 26, 2032 | Method of use | U-3319 | 216196 |
| 11793806 | April 12, 2033 | Method of use | U-3320 | 216196 |
| RE49582 | April 11, 2035 | Drug substance, Drug product | None | 216196 |
| 11234976 | October 11, 2038 | Method of use | U-3321 | 216196 |
| 11254652 | November 21, 2038 | Drug substance, Drug product | None | 216196 |
| 11878049 | July 31, 2041 | Method of use | U-3782 | 216196 |
Pyrukynd exclusivity
| Code | Meaning | Expires | NDA |
|---|---|---|---|
| NCE | New chemical entity | February 17, 2027 | 216196 |
| ODE-392 | Orphan drug exclusivity | February 17, 2029 | 216196 |
Pyrukynd NDC codes
Questions
Is there a generic for Pyrukynd?
No. The Orange Book lists no active FDA-approved generic (ANDA) for Pyrukynd (mitapivat). The Orange Book shows its last listed patent expires July 31, 2041 and its last listed exclusivity ends February 17, 2029.
What is the generic name for Pyrukynd?
The active ingredient in Pyrukynd is mitapivat, per the FDA Orange Book.
When does the Pyrukynd patent expire?
The last patent listed for Pyrukynd in the Orange Book expires July 31, 2041. A listed patent expiry date is not a generic launch date.
What does a therapeutic equivalence code mean?
In the Orange Book, codes that start with A (such as AB) mean FDA considers the product therapeutically equivalent to the reference drug. Codes that start with B mean FDA does not, at this time, consider the product therapeutically equivalent.